Synthes USA, TI Synex (TM) II Central Body 14mm - 19mm, Catalog number 04.808.001. Intended for use in the thoracolumbar
FDA device recall Z-0108-2010 · posted 2009-11-09 · Terminated
Recall details
- Recalling firm
- Synthes USA (HQ), Inc.
- Reason for recall
- loss of device height
- Action taken
- Synthes USA issued an "Urgent: Medical Device Recall" letter to hospital accounts, Synthes personal and sales consultants dated September 23, 2009. Users were asked to take inventory, complete and return a Verification form and return all affected product to the firm. For further information regarding the recall, contact Synthes at 1-800-479-6329 or 1-800-620-7025 extension 5453.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MQP
- Quantity affected
- 267 units
- Distribution
- Worldwide Distribution -- Including the United States and Canada.
- Date initiated
- 2009-09-14
- Date posted
- 2009-11-09
- Date terminated
- 2015-07-09
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES SYNEX SPACER SYSTEM (K003836) | Synthes | 2001-05-29 |